Label: REVIVE FERMITIF NECK RENEWAL BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone, octinoxate, octocrylene, and oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58411-416-50 - Packager: RéVive Skincare
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 24, 2018
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
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Directions
- For sunscreen use:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months of age: Ask a doctor
- For sunscreen use:
- Other information
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Inactive ingredients
Water, Helianthus Annuus (Sunflower) Seed Oil, Butylene Glycol, Cetearyl Alcohol, Squalane, Isocetyl Stearate, Potassium Cetyl Phosphate, PPG-2 Myristyl Ether Propionate, Sorbitan Stearate, Methylsilanol Hydroxyproline Aspartate, Tocopheryl Acetate, sh-Oligopeptide-1, sh-Polypeptide-1, Phenoxyethanol, Terminalia Catappa Leaf Extract, Bisabolol, Dimethicone, Polysorbate 60, Magnesium Aluminum Silicate, Carbomer, Aminomethyl Propanol, Sodium PCA, Allantoin, Caprylyl Glycol, Chlorphenesin, Aloe Barbadensis Leaf Juice, Sambucus Nigra Flower Extract, Disodium EDTA, Fragrance, Glycolipids, PVP, Tannic Acid, Hydrolyzed Soy Flour, Sodium Hyaluronate, Geraniol, Citronellol. May Contain (+/-): Red 33.
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- PRINCIPAL DISPLAY PANEL - 75 g Jar Carton
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INGREDIENTS AND APPEARANCE
REVIVE FERMITIF NECK RENEWAL BROAD SPECTRUM SPF 15 SUNSCREEN
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-416 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 60 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 27 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 20 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SUNFLOWER OIL (UNII: 3W1JG795YI) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SQUALANE (UNII: GW89575KF9) ISOCETYL STEARATE (UNII: 3RJ7186O9W) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) NEPIDERMIN (UNII: TZK30RF92W) BASIC FIBROBLAST GROWTH FACTOR (HUMAN) (UNII: S3529G9M9V) PHENOXYETHANOL (UNII: HIE492ZZ3T) TERMINALIA CATAPPA LEAF (UNII: 4XBZ9J585L) LEVOMENOL (UNII: 24WE03BX2T) DIMETHICONE (UNII: 92RU3N3Y1O) POLYSORBATE 60 (UNII: CAL22UVI4M) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) PYRROLIDONE CARBOXYLIC ACID (UNII: 6VT1YZM21H) ALLANTOIN (UNII: 344S277G0Z) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) ALOE VERA LEAF (UNII: ZY81Z83H0X) SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) TANNIC ACID (UNII: 28F9E0DJY6) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GERANIOL (UNII: L837108USY) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-416-50 1 in 1 CARTON 02/20/2014 1 75 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 02/20/2014 Labeler - RéVive Skincare (193691821)
